Study of the Synchron BCI Brain-Computer Interface for Adults with Bilateral Upper-Limb Paralysis or Motor Neuron Disease in Australia

What this Trial Is About

Researchers are evaluating the Synchron BCI motor neuroprosthesis, an implanted brain-computer interface designed for adults with bilateral upper-limb motor impairment. This device aims to replace motor neuron function by detecting and transmitting motor-related brain signals to restore meaningful control of digital devices. The study focuses on adults with motor neuron disease or paralysis conditions that have not responded to treatment over at least twelve months. Participants will receive the Synchron BCI device called the Stentrode, a device implanted endovascularly to sense electrical signals from the brains sensorimotor areas. The study is a prospective, single-arm, open label trial conducted in Australia. After implantation, participants will undergo clinical testing and training visits both at the study site and in their home environment, supported by caregivers. The study includes follow-up monitoring for device-related serious adverse events up to 12 months post-implant. During the study, participants will be assessed for serious device-related adverse events causing death or increased disability within 3 months and up to 1 year after implantation. Imaging tests such as CT venography and CT scans will be used to evaluate blood vessel patency and device migration at 3 and 12 months. Participants and caregivers must comply with study visits, training, and device use requirements including internet access at home. The total participation period extends up to 12 months after implantation with safety and functional outcomes monitored throughout.

Functional Outcomes and Control Using Synchron BCI - Australia